08:56 AM EDT, 04/16/2024 (MT Newswires) -- BioRestorative Therapies ( BRTX ) said Tuesday that the US Food and Drug Administration has cleared an amendment to the protocol of the current phase 2 trial of its cell therapy candidate, BRTX-100, to treat chronic lumbar disc disease.

The amendment replaces saline injections with sham injections in the control group, the company said, adding it will not impact the study's enrolment completion target.

BioRestorative said it will enroll up to 99 eligible participants in the phase 2 study, which evaluates the safety and efficacy of BRTX-100.

Shares of the company were up over 14% in recent Tuesday premarket activity.